Management of Pediatric Chronic Rhinosinusitis in Asthmatic Children

NCT03336671 | Terminated

• 1 other identifier: 1009628
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study would be to determine the most effective management for pediatric patients with chronic rhinosinusitis and asthma who fail medical management. The Sinus and Nasal Quality of Life Survey (SN-5), a validated tool, will be used to track symptoms of pediatric chronic rhinosinusitis. A decrease in at least 0.5 is felt to represent an improvement in symptom control. In this study, the SN-5 at one year post intervention will be the primary endpoint. Secondary endpoints include complications, revision surgery, and post operative endoscopy scores.

Conditions

Chronic Sinusitis; Adenoid Disease - Chronic

Keywords

Pediatric; Chronic Sinusitis

Outcome Measures

Primary Outcomes (1)

• SN-5 at one year post procedure

  A validated tool used to track symptoms of pediatric chronic rhinosinusitis, improvement greater than 0.5

  One year

Secondary Outcomes (3)

• Revision/Alternate procedure, endoscopic sinus surgery

  Two Years

• Antibiotic use after surgical procedure

  Two years

• Complication Rate

  Two Years

Study Arms (2)

Adenoidectomy

ACTIVE COMPARATOR

Current standard of care for pediatric chronic rhino sinusitis.

Procedure: Adenoidectomy

Adenoidectomy plus Endoscopic Sinus Surgery

EXPERIMENTAL

endoscopic sinus surgery in addition to adenoidectomy

Procedure: Endoscopic Sinus surgery; Procedure: Adenoidectomy

Interventions

Endoscopic Sinus surgery PROCEDURE

Endoscopic sinus surgery would be tailored to abnormal findings in the CT scan, as is the standard of care. Radiologists typically examine sinonasal disease of the sinuses, and they would also be requested to comment on the patency of the osteo-meatal unit, as this is a component of the Lund-McKay score. The Lund-McKay score is an objective radiologic grade of the severity of sinusitis. If there is sinus thickening, or narrowing of the OMU, endoscopic sinus surgery would be tailored to this using either balloon sinuplasty or traditional antrostomy. Patient undergoing endoscopic sinus surgery will likely have at least a maxillary antrostomy and anterior ethmoidectomy performed, with frontal sinusotomy, posterior ethmoidectomy, and sphenoidotomy performed depending on CT or endoscopy findings.

Also known as: Functional Endoscopic Sinus Surgery

Adenoidectomy plus Endoscopic Sinus Surgery

Adenoidectomy PROCEDURE

Adenoidectomy performed, routine, as a singular procedure not combined with any sinus surgery.

Adenoidectomy; Adenoidectomy plus Endoscopic Sinus Surgery

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 6-12 at time of study enrollment.
• Presence of chronic sinusitis: \>90 days 2 or more symptoms of purulent rhinorrhea, nasal obstruction, facial pressure/pain, or cough
• Presence of asthma, as documented in the medical record by the patient's pediatrician and/or pulmonologist
• Failure of medical management of pediatric chronic rhinosinusitis, which current guidelines recommend extended empiric antibiotics for 21 days, which will be either Augmentin or clindamycin in penicillin allergic patients, at standard pediatric weight based dosing. In addition, Flonase nasal spray and nasal saline treatment for three weeks. Failure is considered persistent symptoms despite treatment with the above within the past year.

You may not qualify if:

• Previous sinus surgery,
• Previous adenoidectomy, or
• Presence of cystic fibrosis,
• Presence of antrochoanal polyp,
• Immunodeficiency
• Fungal infection.

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13202, United States

Location

MeSH Terms

Interventions

Adenoidectomy

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Haidy Marzouk, MD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

• Mark Arnold, MD

  315 464-4678

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective Randomized Controlled Trial

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: November 8, 2017
• Study Start: July 1, 2017
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: October 13, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)